—#165634

Product

Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,

FDA product code: OAD — Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P020025, P920047, P980003
Affected lot / code info: All Maestro 4000 Generators used with the optional foot switch.

Why it was recalled

Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.

Action the firm took

On 06/20/2018, a system notice was sent to customers, informing them that releasing the foot switch may not stop RF delivery. If RF delivery does not stop as intended, press and release the RF Power Control button. Customers were advised to report occurrence and clinical outcome of unintended RF delivery to the firm:United States (1-800-949-6708), Europe, Middle East, and Africa (+800-5555-7707), Asia Pacific (+65-6418-8878). Notification outside of the U.S. started 06/21/18. On 09/20/2019, a System Correction Notice was sent to Cath/EP Lab Managers informing them that the firm will begin the process of upgrading the firmware of affected cardiac ablation systems. The firmware update will eliminate one potential cause of this behavior. Residual risks for other potential causes of RF termination delay remain. Cath/EP Lab Managers were asked to distribute the notice within their respective facilities, continue to post a copy of Appendix A of the June 2018 notice near each affected system, allow the recalling firm to access affected systems for the firmware update, and to complete, sign, and return the acknowledgement form.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: U.S.: PA, IL, NY, CA, SC, AR, SD, AZ, KY, FL, TX, MA, MI, OH, LA, VA, NC, WA, DE, IN, TN, NJ, CT, AL, ME, GA, NH, MN, MD, DC, OK, HI, WI, CO, MO, IA, GU, NE, OR, ID, UT, RI, KS, NV, MS, WV Foreign (OUS): Canada, Albania, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Lithuania, Namibia, Netherlands, Lebanon, Pakistan, Poland, Portugal, Russian Fed., Saudi Arabia, South Africa, Spain, Sudan, Sweden, Switzerland, Turkey, Unit.Arab Emir., Argentina, Australia, Bangladesh, Chile, China, Colombia, Japan, Malaysia, Mexico, Nicaragua, Panama, Philippines, Sri Lanka, Taiwan, Thailand, Vietnam

Timeline

Recall initiated: 2018-06-20
Posted by FDA: 2018-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #165634. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.